Patients must be consented before they can be enrolled in the study. Patients should only be consented and enrolled in the study if they meet ONE of following conditions:
(1) The patient has had an MRI and meets all eligibility criteria
(2) An MRI has been ordered AND the patient will not return to clinic to receive their results (per physician practice)
(3) The patient will receive a research MRI to determine eligibility for the study
(4) The patient is eligible but needs more time to decide and cannot return for a research visit to perform enrollment procedures
NOTE: The conditions for enrollment in the study are not the same as the conditions for randomization. (See question “When should a patient be randomized” below for more information.)